Diaphragmatic Mobility In Ventilated Assisted Patients

September 2, 2021 updated by: Mir Arif Hussain, Aqua Medical Services (Pvt) Ltd

Effectiveness Of Diaphragmatic Mobility In Ventilated Assisted Patients

The study was a randomized controlled trial. A total of 24 patients who met the inclusion criteria were included in this study and randomly divided by sealed envelope method into Experimental and Control groups with 12 patients each. Assessment of arterial blood gas analyzer (oxygen saturation(SP02), heart rate (HR), respiratory rate(RR), the partial pressure of carbon dioxide(PCO2), the partial pressure of oxygen(PO2), Bicarbonate(HCO3), and potential of hydrogen(PH) and modes of the ventilator (SIMV and PSV) for both groups were carried out at baseline and after 4thsession.The control group was given Chest physiotherapy only. While the Experimental group received Chest physiotherapy with Diaphragmatic Mobility. Total 4 sessions were given on alternate days to both groups.

Study Overview

Detailed Description

Most common state in the intensive care unit is an intensive care unit acquired weakness in seriously unwell patients who are artificially ventilated for an extended period of time. The most important aspect of mechanical ventilation in the disuse atrophy and deconditioning of a patient's inspiratory muscle since it can replace the patient's own respiratory muscle exertion. The diaphragm particularly counters to persistent mechanical ventilation with atrophy. Most sufferers who are admitted to an intensive care unit need artificial aeration. Due to weaknesses of respiratory muscle might augment the interval of mechanical ventilation and delay the phase of withdrawal of mechanical ventilation. The term weaning is used for the course of withdrawal of artificial aeration to facilitate the patient's own respiratory muscle effort in the intensive care unit. Ventilation is universal work, linking the entire body, the emotions, the nervous system and organs. The diaphragm is the primary breathing muscle that influencing with its contraction the inspiratory actions. Diaphragmatic breathing is recognized as normal breathing which involves corresponding movement of abdomen, upper and lower ribcage. Furthermore, functionality and sufficient use of the diaphragm muscle requires usual breathing. Thoracic breathing is recognized as unusual breathing that involves aeration from the upper chest, evidence by bigger upper rib cage movement, compare to lower rib cage movement. Weakness possibly will owe an extreme weight on the respiratory muscle, which might affect starting augmented airway conflict and also over-come lung compliance. Two most important factors that are broadly known as a reason of malfunction to with-drawl from mechanical ventilation are weakness or fatigue of diaphragm and accessory muscle of respiration. A dome-shaped muscular membrane that separates the abdomen from thoracic is a diaphragm. Nine hundred centimetre per square area is covert in adults. It is the most important and primary inspiratory muscle and it is able to condense itself to forty per cent as of residual to vital capacity. In fact, a one-sided paralysis of the phrenic nerve generates merely respiratory dysfunction because the stomach has the widespread capacity to functional preserved. The weakness of diaphragm muscle tends to be more worse in patients who are mechanically ventilated for a prolonged period of time with controlled modes of mechanical ventilator compared to spontaneous modes and also appear to be interrelated to patients voluntary inspiratory exertion even as ventilator-dependent. During inspiration, throughout the application of resistance in inspiratory muscles that may help in strengthening of inspiratory muscle and this technique is known as inspiratory muscle training. Patients who have difficulty in breathing and mechanically ventilated for more than 24 hours possibly will adversely affect diaphragmatic structure and function. Major factors such as reduced quality of life, increase the length of stay in the intensive care unit, increase death rate and reduced functional grades are due to extended artificial aeration. Moreover, extended artificial aeration is cheap, unbearable a big portion of hospital assets and a healthcare load that might keep on subsequent hospital ejection. An intervention invented to directly stretch the muscle fibre of diaphragm is known as the manual diaphragm release technique. Even though this intervention is widely used in some regions, there is no quantitative research or systematic trails or evaluating the result of this technique. The previous research conducted to find out the outcome of manual diaphragm release technique in chronic obstructive pulmonary disease. The objective of the study was to determine the effects of diaphragmatic mobility on improving ventilation in ventilated assisted patients, to determine the effects of diaphragmatic mobility in weaning off from mechanical ventilation in ventilated assisted patients, and to determine the additional effects of diaphragmatic mobility on respiration along with Chest Physical Therapy.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Aqua research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 30 to 60
  • Oro-tracheal or nasotracheal intubate; ventilator mode:- Synchronized intermittent mechanical ventilation(SIMV) or Pressure support SIMV
  • Both Gender included have been aeration used for Acute Respiratory Failure( type 2) during SIMV/PSV used for at any rate 72 hours consecutively
  • Hemodynamically secure with no vasopressin or else inotropes (apart from a dobutamine and dopamine infusion lesser than 5 gamma/Kg/min and a 3 gamma /Kg/min, correspondingly
  • Positive end-expiratory pressure 5 to 7cm H2O

Exclusion Criteria:

  • Neurological or neuromuscular disorders
  • Dysfunction of Phrenic Nerve
  • Insertion of a nasogastric tube (for example recent upper gastrointestinal surgery, oesophagal varies).
  • Pulmonary embolism, Malignancy, Pneumothorax, trauma, fever
  • Acutearrhythmias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diaphragmatic mobility
The patient will be in supine, supported on one/two pillows under her head, and a bolster under her knees.
Therapist will manually make contact with Pisiform Hypothenar region and last three fingers among the underneath the costal cartilage of the 7th in the direction of 10 ribs. For the duration of participant's inhalation, the counselor drag softly within a upward course accompany the increase motion of the ribs. For the period of expiration, the counselor will deepens make contact with in the direction of the internal costal border. Taking place consequent breathing, the counselor wanted on the way to expand traction as well as slickly make deeper the contact.
Experimental: Chest Physiotherapy
Give passive ROM exercise to all joints of the upper and lower extremities.
Patients allocated to the control group and interventional group received pulmonary rehabilitation two times a day beginning happening the day of entrance on the way to the intensive care unit. It consists of side-lying positioning with the head of the bed horizontal for at least 20 min with the most affected lung on chest x-ray positioned uppermost is also known as postural drainage, 4 sets of 6 cycles of expiratory chest wall vibrations , and airway suctioning at least three times through the endotracheal and tracheotomy tube disperse in the course of the management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Synchronized Intermittent- Mandatory Ventilation (SIMV)
Time Frame: 0 day
Synchronized intermittent mandatory ventilation is a ventilator mode that enables partial mechanical assistance. This ventilator mode will provide a set number of breaths at a fixed tidal volume, but a patient can trigger a spontaneous breath with the volume determined by patient effort
0 day
Pressure Support Ventilation (PSV)
Time Frame: 0 day
For the spontaneously breathing patient, pressure support ventilation (PSV) has been advocated to limit barotrauma and to decrease the work of breathing. ... Airway pressure support is maintained until the patient's inspiratory flow falls below a certain cutoff (eg, 25% of peak flow).
0 day
Synchronized Intermittent- Mandatory Ventilation (SIMV)
Time Frame: 4th day
Synchronized intermittent mandatory ventilation is a ventilator mode that enables partial mechanical assistance. This ventilator mode will provide a set number of breaths at a fixed tidal volume, but a patient can trigger a spontaneous breath with the volume determined by patient effort
4th day
Pressure Support Ventilation (PSV)
Time Frame: 4th day
For the spontaneously breathing patient, pressure support ventilation (PSV) has been advocated to limit barotrauma and to decrease the work of breathing. ... Airway pressure support is maintained until the patient's inspiratory flow falls below a certain cutoff (eg, 25% of peak flow).
4th day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Blood Gas ( ABGs) Test
Time Frame: 0 day,4th day
An arterial-blood gas test measures the amounts of arterial gases, such as oxygen and carbon dioxide. An ABG test requires that a small volume of blood be drawn from the radial artery with a syringe and a thin needle, but sometimes the femoral artery in the groin or another site is used.
0 day,4th day
Peripheral Capillary Oxygen Saturation (SPO2)
Time Frame: 0 day,4th day
SpO2 stands for peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. More specifically, it is the percentage of oxygenated haemoglobin (haemoglobin containing oxygen) compared to the total amount of haemoglobin in the blood ( oxygenated and non-oxygenated haemoglobin).
0 day,4th day
Chest X-ray
Time Frame: 0 day,4th day
The chest x-ray is the most commonly performed diagnostic x-ray examination. A chest x-ray produces images of the heart, lungs, airways, blood vessels and the bones of the spine and chest.
0 day,4th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dr Abdul Ghafoor Sajjad,, PHD*, Shifa Tameer e milat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2020

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventilation Therapy; Complications

Clinical Trials on Diaphragmatic mobility

Subscribe